POS1601-HPR ADVERSE EVENTS AND ADVERSE REACTIONS WITH THE USE OF ANTITNF’S DETECTED BY THE PHARMACOVIGILANCE PROGRAM OF A SPECIALIZED RHEUMATOLOGY CENTER
Authors: W. Rivero, P. Rodríguez-Linares, F. Rodriguez, G. S. Rodríguez-Vargas, A. Rojas-Villarraga, P. Santos-Moreno
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Pharmacovigilance is the science that is responsible for the detection, notification, and monitoring of possible drug adverse events (DAE) that occur with the administration of medications. In the pharmaceutical service process, the information generated through its programs constitutes evidence that provides a solution to the management of drug-related problems, especially those obtained by biotechnology. <h3>Objectives</h3> The aim of this study is to show the main DAEs and drug adverse reactions (DARs) with the use of anti-TNF (Anti-Tumor Necrosis Factor) drugs detected by the Pharmacovigilance program of an IPS specialized in rheumatology during the period 2018-2022. <h3>Methods</h3> The current method carried out in the institution is the so-called S<i>pontaneous Notification</i>. A retrospective review of the DAE and DAR detected by an institutional Pharmacovigilance program with the use of Anti-TNF drugs, in patients with autoimmune diseases, during the period 2018-2022, was carried out. Indicators were established through descriptive statistics to measure the frequency of DAE and DAR. <h3>Results</h3> 408,914 medical records were reviewed, the Table 1 shows the comparative percentages of DAE and DAR detected by the program between conventional disease-modifying antirheumatic drugs (csDMARDs) and biologics during the follow-up period. The Pharmacovigilance program had growth in the detection of DARs with the use of anti-TNF drugs, strengthening knowledge in the information for these. The causality with the anti-TNF was established, being the DAE classified as probable and the DAR as possible. Of the total subgroup of patients treated at the institution for medication application (46,832), notifications were received as follows: (Infliximab 17, Etanercept 17, Adalimumab 22, Golimumab 15, Certolizumab 51). Additionally, dermatological reactions are the most recurrent types of reactions. Herpes is found as the main DAR with Certolizumab in the last year. According to the results obtained, Certolizumab is the drug that has presented the most adverse reactions during the follow-up period (Figure 1). <h3>Conclusion</h3> Dermatological reactions are the most frequent with anti-TNF drugs. Infliximab and Certolizumab stand out for this type of commitment. Studies are needed in populations from the same country to compare these results and generate more knowledge. <h3>Acknowledgements</h3> We thank the Asistencial Direction and the BIOMAB clinical reports department for their support in creating the database to carry out this study. <h3>Disclosure of Interests</h3> Wilberto Rivero: None declared, Pedro Rodríguez-Linares: None declared, Fernando Rodriguez: None declared, Gabriel-Santiago Rodríguez-Vargas: None declared, Adriana Rojas-Villarraga: None declared, Pedro Santos-Moreno Speakers bureau: Abbvie, Abbott, Biopas-UCB, Bristol, Janssen, Pfizer, Roche, Sanofi, Grant/research support from: Abbvie, Abbott, Biopas-UCB, Bristol, Janssen, Pfizer, Roche, Sanofi.